Continuing care through Telecounselling in Alcohol de-addiction Program: A Randomized Controlled study

CONTINUING CARE THROUGH TELE-COUNSELLING IN ALCOHOL DE-ADDICTION PROGRAM–A RANDOMIZED CONTROLLED STUDY

Submitted

BY

DR.PRANESH .R. R. MBBS

Dissertation submitted to

THE TAMILNADU DR.M.G.R. MEDICAL UNIVERSITY, CHENNAI, In partial fulfilment of the requirements for the degree of

DOCTOR OF MEDICINE IN PSYCHIARY 2014

Under the guidance of Dr. G. RAGHUTHAMAN

Professor & Head

DEPARTMENT OF PSYCHIATRY,

DECLARATION BY THE CANDIDATE

I hereby declare that this dissertation entitled “Continuing care through tele-counselling in alcohol de-addiction program–A randomized controlled study”is a

bonafide and genuine research work carried by me under the guidance of Dr. G.Raghuthaman, Prof and Head, Department of Psychiatry, PSGIMS & R,

Coimbatore.

PLACE: COIMBATORE DR.PRANESH.R.R

CERTIFICATE BY THE GUIDE

This is to certify that this dissertation entitled“Continuing care through tele -counselling in alcohol de-addiction program–A randomized controlled study

” is a bonafide work done by

Dr.Pranesh.R.R.

PLACE: COIMBATORE DR.G. RAGHUTHAMAN M.D

DATE: PROFESSOR & HEAD

DEPARTMENT OF PSYCHIATRY

ENDORSEMENT BY THE HOD/PRINCIPAL OF THE INSTITUTION

This is to certify that this dissertation“Continuing care through tele-counseling in alcohol de-addiction program– A randomized controlled study”is a bonafide research work done

by Dr.PRANESH.R.R under the guidance of Dr. G. RAGHUTHAMAN, Professor & Head, Department of Psychiatry, PSGIMS&R, Coimbatore.

Dr. RAMALINGAM M.D DR. G. RAGHUTHAMAN M.D

Principal, Prof. and Head.

PSGIMS&R, Department of Psychiatry, Coimbatore. PSGIMS&R, Coimbatore

DATE:

ACKNOWLEDGEMENT

At the outset, I thank God for giving me the strength to perform all my

duties.

It is indeed a great pleasure to recall the people who have helped me in

the completion of my dissertation. Naming all the people who have helped me

in achieving this goal would be impossible, yet I attempt to thank a selected

few who have helped me in diverse ways.

I acknowledge and express my humble gratitude and sincere thanks to my

beloved teacher and guideDr. G. Raghuthaman,M.D (Psychiatry), Professor &

HOD, Department of Psychiatry, PSGIMS&R, Coimbatore for his valuable

suggestion, guidance, great care and attention to details, that he has so

willingly shown in the preparation of this dissertation.

I owe a great deal of respect and gratitude to all my Professors,

Associate Professors and Assistant Professors, Department of Psychiatry,

PSGIMS&R, Coimbatore for their whole hearted support for completion of this

dissertation.

I am immensely indebted to my parents who have inculcated the proper

habits and characters in me.

My sincere thanks to all my post graduate colleagues and my friends for

their whole- hearted support.

Finally, I thank my patients who formed the backbone of this study,

without them this study would have not been possible.

PLACE: Dr.PRANESH.R.R

INDEX

S No.

Table of Contents

Page Number

1.

Abstract

16

2.

Introduction

18

3.

Rationale for the

study

21

4.

Review of Literature

22

5.

Aims and objectives

31

6.

Methodology

32

7.

Results

40

8.

Discussion

43

9.

Limitations

104

10.

Conclusion

106

11.

Bibliography

107

LIST OF TABLES

TABLE 1: BASELINE SOCIO DEMOGRAPHIC DETAILS OF THE STUDY SAMPLE

TABLE 2: BASELINE CLINICAL CHARACTERISTICS OF THE STUDY SAMPLE

TABLE 3: BASELINE ALCOHOL PROFILE OF STUDY SAMPLE

TABLE 4: ABSTINENT EPISODES PROFILE OF STUDY SAMPLE

TABLE 5:BASELINE HISTORY OF COMPLICATED WITHDRAWAL SYMPTOMS

TABLE 6 :BASELINE ALCOHOL SEVERITY PROFILE OF SAMPLE

TABLE 7:BASELINE MOTIVATION PROFILE OF STUDY SAMPLE

TABLE 8: DEADDICTION TREATMENT PROFILE OF STUDY SAMPLE:

TABLE 9: HOSPITAL STAY DURATION

TABLE 10:BENZODIAZEPINE USAGE DETAILS OF STUDY SAMPLE

TABLE 11:ABSTINENT MAINTAINING MEDICATIONS

TABLE 12: ABSTINECE AND RELAPSE OUTCOME IN TCC AND TAU GROUPS:

TABLE 13: ABSTINECE AND RELAPSE OUTCOME IN TCC AND TAU GROUPS:

TABLE 15: DRINKING PERCENTAGE DAYS IN TWO GROUPS:

TABLE 16: COMPARISON OF DRUG COMPLIANCE BETWEEN TWO GROUPS

TABLE 17: COMPARISON OF LENGTH OF FOLLOW- UP BETWEEN TWO GROUPS

TABLE 18: COMPARISON OF GROUP VISITS ATTENDANCE BETWEEN TWO GROUPS

TABLE 19: COMPARISON OF RE-ADMISSIONS BETWEEN TWO GROUPS

TABLE 20: COMPARISON OF DROP-OUTS BETWEEN TWO GROUPS

TABLE 21 : COMPARISON OF DRINKING FREQUENCY WITH THEIR BASELINE

TABLE 22: ASSOCIATION OF STUDY GROUP AND RELAPSE RISK

TABLE 23: ASSOCIATION OF SOCIODEMOGRAPHIC FACTORS AND RELAPSE:

TABLE 24: ASSOCIATION OF OTHER BASELINE DETAILS AND RELAPSE

TABLE 25: ASSOCIATION OF ALCOHOL PROFILE AND RELAPSE:

TABLE 26: ASSOCIATION OF TREATMENT VARIABLES AND RELAPSE

TABLE 27: ASSOCIATION OF FOLLOW UP TREATMENTS AND RELAPSE

TABLE 29: COMPARISON OF DEMOGRAPHIC AND BASELINE ALCOHOL PROFILE OF SAMPLE IN OUR STUDY WITH OTHER INDIAN OUTCOME STUDIES

TABLE 30 : COMPARISON OF POSITIVE FAMILY HISTORY OF ALCOHOLISM WITH OUTCOME STUDIES

TABLE 31 : COMPARISON OF ABSTINENT RATE BETWEEN TWO GROUPS AT EACH MONTH

TABLE 32: COMPARISON OF ABSTINENT RATE WITH OTHER OUTCOME STUDIES

LIST OF FIGURES

FIGURE 1: FLOW CHART DESCRIBING THE METHODOLOGY

FIGURE 2: COMPARISON OF ABSTINENCE BETWEEN TWO GROUPS

FIGURE 3: COMPARISON OF DRUG COMPLIANCE BETWEEN TWO GROUPS

FIGURE 4: COMPARISON OF LENGTH OF FOLLOW UP BETWEEN TWO GROUPS

FIGURE 5: COMPARISON OF GROUP VISITS ATTENDANCE BETWEEN TWO GROUPS

FIGURE 6: COMPARISON OF MONTHLY DRINKING FREQUENCY OF RELAPSED PATIENTS

LIST OF APPENDICES

APPENDIX 1: SCID QUESTIONNAIRE

APPENDIX 2: DSM–IV-TR ALCOHOL DEPENDENCE CRITERIA-DIAGNOSTIC CODE 303.90

APPENDIX 3: SADQ–C SEVERITY OF ALCOHOL DEPENDENCE QUESTIONAIRE

APPENDIX 4: SADQ–C SEVERITY OF ALCOHOL DEPENDENCE QUESTIONAIRE (TAMIL VERSION)

APPENDIX 5: URICA–ENGLISH VERSION

APPENDIX 6: URICA (TAMIL VERSION)

APPENDIX 7: INFORMED CONSENT

APPENDIX 8: INFORMED CONSENT (TAMIL VERSION)

-ABSTRACT

Continuing Care Through Tele-Counselling in Alcohol De-Addiction

Program–A Randomized Controlled Study

INTRODUCTION

There is a rising trend of alcohol addiction in our Indian society. Promised by

the effectiveness of western studies in using telephone based counselling

services and the availability of extensive mobile phone services in our part, we

did this novel study, first of this kind in India

Type of the study: Prospective randomized controlled study

METHODOLOGY:

We recruited admitted in-patients qualified for alcohol dependence and

randomized them at the time of discharge into two groups: 1) ‘Telephone Continuing Care’ group(TCC) who received pro-active contact and

counselling through mobile phones from the treatment team at 1st, 2nd, 4th, 8th,

12th, 16th, 20thand 24th week after discharge. 2)‘Treatment-As-Usual’ group (TAU) received usual out-patient follow-up care. We contacted patients and

their care-givers, belonging to both groups, each month over mobile phone and

drinking percentage days and treatment adherence rates. By including all the

variables, we did logistic regression to predict relapse.

RESULTS

There was no statistical significance between two groups in terms of

abstinence rate (TCC: 66.7% and TAU: 55.6%); however among the group

from whom complete data was obtained abstinence rate was slightly better in

TCC group (TCC: 67.9% and TAU: 43.8%, p=0.06). There was no difference

in the drinking percentage days.TCC group was significantly better than TAU

group in having longer duration of follow-up, good drug compliance, adherence

to group meetings and lower dropout rate. Logistic regression revealed that

family history of alcoholism, three weeks admission for de-addiction, drug

compliance and length of follow-up were found to be significant predictors of

relapse.

CONCLUSION

Telephone continuing care showed few positive findings in improving the

outcome and this could be included in the armamentarium of de-addiction

program.

INTRODUCTION:

Alcohol dependence is a chronic condition with multiple

relapses. According to WHO statistics, in 2010-11, there were nearly 1.8

million alcohol related deaths which is 3.2% of total deaths in that year. In India

alone, there were 62.5 million alcohol users with 17.4% of them (10.6 million)

fulfilling criteria for dependence [1, 2].

Treatment of alcohol addiction is a challenging task, requiring

a multistep approach for sustaining recovery from addiction. Treatment

focussing mainly on ‘acute crisis management’ of alcohol dependence failed to give sustained recovery due to higher relapse rates [3, 4, and 5]. Many outcome

studies[6,7,8,9] proved extended continuing care in managing alcohol addiction

to be effective. This continuing care is comparable to the care in managing

chronic mental illness such as Depression[10,11], Obsessive Compulsive

Disorders[12,13] and as well as in chronic physical diseases such as

Dropout rate was high in case of ‘face-to-face interview type’ continuing care [17, 18, and 19]. This could be because of stigma attached to

visiting mental health centres [20, 21, and 22] shortage of manpower,

inadequate infrastructure and long distance with difficult transportation

facilities. So, there is a need for an alternative to the usual ‘face-to-face interview type’ of continuing care. Telephone based follow up care offers a more feasible form oftaking care of patients’ inconveniences[23, 24].

American Society of Addiction Medicine 2001[25] and McKay 2005[26]

clearly reported about effectiveness of both ‘face to face interview’ and ‘telephone based’ continuing care in treating substance use disorders. Other studies focussing on continuing care through telephone also proved benefits in

controlling alcohol addiction [3,24,27,28,29] , other substance use

All the above studies were done in western countries and there is no

published research in India, where the need of telephone based continuing care

is large.

According to the report of Ministry of Telecommunications [34],

India has 9435.03 lakhs of telephone connections (Urban - 6187.72 lakhs and

Rural - 3247.31 lakhs). Currently, our tele-density stands at 78.10% and it has

been increasing by 12.7% every year. With more than two-thirds of the

population having access, telephone based follow-up care could be feasible and

effective among patients.

There is a rising trend of alcohol addiction in our Indian society [35, 36]

and the traditional de-addiction treatments had yielded abstinence rates of

12.3% [17], 32.5% [37] and 55% [38]. Such a low success rate is not acceptable

and we have to look for alternative mode which improves treatment delivery

RATIONALE OF THE STUDY:

Promised by the effectiveness of western studies in using telephone based

counselling services and the availability of extensive mobile phone services in

our part, we had planned this study.

Among patients who received in-patient treatment for alcohol dependence

syndrome, we compared the effectiveness of abstinence rates and compliance

REVIEW OF LITERATURE:

Alcohol dependence and its effective management was always a

tricky condition. Successful treatment depends on several factors. Search for

effective tools in improving the outcome of treatment of alcohol addiction has

always been a burning issue.

Telephone based interventions have been studied previously. Considering

easy availability and cost effectiveness, studies have shown telephone based

interventions to be helpful in improving the outcome results in common

non-communicable disorders such as Diabetes and Hypertension [14, 15].

Similarly, to improve the outcome measures in the management of substance

disorders, few studies have been carried out [4, 7]. Results in substance

Hubbard et al (2007) [30] carried out a study to find out the effectiveness

of telephone based interventions in management of nicotine disorders. Study

showed better outcomes in patients had received telephone based interventions

in smoking cessation. Similarly, other outcome studies and meta-analytic

review on substance disorders showed encouraging results in controlling

substance disorders. [29, 32, 33]

There were many studies done in western countries to find out the ways of

improving outcome measures in the management of alcohol addiction. [3, 6, 18]

Continuing care through telephone based counselling forms the recent decade

trend of improving management strategies for substance disorders.

Most of the studies were longitudinal prospective studies to find out

effectiveness of tele-counselling in alcohol de-addiction programme. Very few

were randomized controlled trials comparing telephone based continuing care

In 2010, Godley et al [6] did their study in Illinois, United States. Their

study included 104 subjects fulfilling criteria for alcohol dependence, who were

admitted for residential treatment for alcohol de-addiction. They were

randomized into two groups.

One group, telephone based continuing care, comprised of 51 patients who

received proactive tele-counselling for first three months and the other group,

usual continuing care, comprised of 53 subjects. Mean age of subjects was

31.6 years. They were followed up for 6 months period.

Telephone based care group received counselling sessions from the treating

team once a week in the first month and then every fortnight over the next two

months. In last three months, they were contacted once a month.

At the end of 6 months study, there was no significant difference in the

abstinence rate between the two groups (87.39 % in telephone group vs. 84.64

% in usual treatment group). But in the lower severity group of alcohol

dependent patients, there was a statistical significant difference in the

abstinence rate at the end of 3 months, however this statistical significance was

Similarly, there was no significant difference in outpatient session

attendance and Substance Problem Scale between two groups. Although there

was a trend towards significance at the end of three months (0.06), there was no

major difference in outcome measures between two groups.

Mckay et al (2005) [3] conducted a longitudinal prospective study in

Philadelphia, United States to find out the effectiveness of telephone based

counselling in managing alcohol and cocaine disorders. The total sample was

359 subjects, of which 91 patients were having alcohol dependence alone and

remaining 268 patients were having comorbid cocaine dependence.

The sample was divided into three groups. The first group received

telephone based monitoring and brief counselling. The second group was

relapse prevention group and the third one was standard 12 step group

counselling group. Both relapse prevention group and standard 12 step group

They were followed up for 2 years and outcomes at the end of 1st year and

2ndyear were published.

At the end of first year, the study did not find any superiority of telephone

based monitoring group in outcome measures over face-face interventional

groups.

At the end of 2 years, telephone based group had higher rates of total

abstinence than standard 12 step counselling group (p <0.05). Also 24 month

gamma glutamyl transferase level in telephone group was lower compared to

relapse prevention face-to-face group (p=0.05).The results were more

significant for alcohol outcome measures than for cocaine.

The above few studies done in western countries compared the

effectiveness of telephone based care in treating alcohol disorders. In India,

there has not been any published article regarding telephone continuing care in

treating alcohol dependence. However, there are many outcome studies done in

India to find out the effectiveness of alcohol deaddiction treatment and

Abraham et al (1997) [37] carried out a one year prospective

study at JIPMER, Pondicherry. They recruited the patients admitted in the

hospital for alcohol de-addiction treatment, which included detoxification,

group sessions and disulfiram medications. Sixty patients were followed up for

a year.

Mean age of the sample was 39.6 years (±8.5). 81.6% of total subjects

were married. 54.5 % had family history of alcoholism.

They were advised to come for follow-up every two weeks after

discharge. Out of the 60 subjects, only 9 patients had follow-up in clinic at the

end of a year. Thirty one patients had follow-up for less than 3 months and 10

patients were attending for period of 3-6 months. The remaining 10 patients

At the end of one year, 32.5% patients remained abstinent; 35% of

patients continued drinking but improved compared to previous drinking pattern

and; 32.5% patients continued to have unimproved drinking pattern.

Chandrasekaran et al [17], 2001 did a retrospective study at

JIPMER, Pondicherry to find out follow up rates of patients treated for alcohol

addiction. They recruited 800 alcohol dependence patients treated over five

years period.

Mean age of the subjects was 39.7 years (±8.66). Recruited

patients had moderate severity of alcohol dependence, indicated by their mean

SADQ score was 23.95.

Out of 800 patients, only 28 patients (4.6%) were on regular follow

up for 1 year; 48 patients (7.9%) were on regular follow for 6-12 months and;

152 patients (25.1%) were coming for follow up for less than 6 months period,

There was a very high drop-out rate. Within one month 379 patients

(62.4%) dropped out from treatment, which is significantly high compared to

other contemporary Indian studies. [37, 38]

Kar et al [38], 2003 carried out one year prospective study in

Kasturba Medical College, Manipal.

They recruited 60 patients who fulfilled the criteria for alcohol

dependence and admitted for de-addiction treatment, which includes

detoxification, psychoeducation, aversion therapy, group therapy and disulfiram

medication.

Mean age of the sample was 42.86 years. Recruited patients had onset

of regular drinking around 30.85 years. Around 92% of the recruited patients

were prescribed disulfiram at the time of discharge. They were followed up for

At the end of one year 28 patients (46.7%) were abstinent. Five

patients (8.3%) were drinking occasionally and 21 patients were having >50%

drinking days. Remaining 6 patients (10%) were drop outs.

Greater the average age of problem drinking, lower psychosocial

problems and lack of family history of alcoholism were found to be predictors

AIMS & OBJECTIVES:

Our aim was to assess the effectiveness of providing continuing care

through telephone to patients who had received in-patient de-addiction

treatment. We also aim to find out the risk factors that would predict relapse in

the whole sample.

Our objectives are:

1. To prospectively study the abstinence rate between two groups: a)

Telephone Continuing Care (TCC) and b) Treatment As Usual (TAU).

2. To study secondary outcome measures such as drinking frequency, length

of abstinence ,drug compliance and length of follow-up in clinic in the

above 2 groups.

3. To assess the rate of abstinence and relapse among patients for whom we

got complete follow-up data for 6 months (Completers).

METHODOLOGY

All patients admitted to the Department of Psychiatry with the clinical

diagnosis of Alcohol Dependence Syndrome were administered SCID

(Structured Clinical Interview for DSM disorders) and patients who qualified

for the DSM IV TR diagnosis of Alcohol Dependence Syndrome were

recruited for our study. We assessed the severity of dependence by using the

Severity of Alcohol Dependence Questionnaire (SADQ). We assessed the

motivational level of recruited patients using University of Rhode Island

Change Assessment Scale (URICA).

SADQ is 20-item self administered questionnaire developed by

Stockwell et al [39] for assessing the severity of alcohol dependence. We used

SADQ–community version which measures the severity of alcohol dependence in last three months. It was measured in 0-3 point scale with a maximum score

of 60. A score of greater than 30 was considered as severe alcohol dependence.

University of Rhode Island Change Assessment Scale (URICA) is a

questionnaires. We used 12-item scale for the current study. The results were

described in four stages : Precontemplation, Contemplation, Action and

Maintenance. The items of SADQ and URICA were translated from English to

Tamil and back translated to English by2 independent persons. We used the

Tamil version of SADQ and URICA on our patients.

After admission, all these patients were offered the standard treatments

practised in the Department of Psychiatry. Initially all of them had

detoxification treatment and majority of them underwent de-addiction treatment

which include motivational interviews, Cue Analysis, Cue Management, Covert

Sensitization, Aversion Therapy and Group Therapy. They were discharged

with medications to maintain abstinence.

Patients who have phone connections either landline or mobile were

only included in the study. Patients with co-morbid severe mental disorder and

cognitive impairments were excluded from the study.

At the time of discharge from the hospital, we randomized the patients

into 2 groups: 1) Telephone Continuing Care (TCC) and 2) Treatment As Usual

Telephone Continuing Care (TCC):

We contacted patients belonging to this group at the following frequency:

1st, 2nd, 4th, 8th, 12th, 16th, 20thand 24thweek after discharge. During such

contacts, five-minute proactive counselling was provided on the following

themes:

a) Enquiring about abstinence and encouraging remaining so.

b) Probing for ‘craving’ and practice of ‘relapse prevention strategies’. c) Discussing health hazards he had sustained due to alcohol.

d) Ensuring compliance with medications.

e) Encouraging attendance for group therapy.

f) Advising to attend follow-up visits at the de-addiction clinic.

Patients belonging to this group also were getting the standard treatment at the

hospital: attending de-addiction clinic, participation in group therapy and seeing

their primary therapists.

Treatment As Usual (TAU):

Patients belonging to this group were receiving follow-up treatments

from their respective primary therapists. They received psychological treatment

and medications during their consultations. They were encouraged by their

Assessments:

We contacted patients and their primary carers belonging to both

the groups at 4th, 8th, 12th, 16th, 20th, 24th week over mobile phone or telephone.

During that time we conducted semi-structured interviews to get information

regarding the drinking status of the patients. In case, patient had restarted

drinking, we got the following information: number of drinking days in the

previous 4 weeks and about number of drinks per day. The information obtained

from the patients and their primary carers were recorded separately.

The primary outcomes were Abstinence and Drinking percentage days.

We analysed abstinence by dividing into 4 groups:

1) Abstinence: Patient had not touched alcohol

2) Occasional drinking: Patient had taken alcohol but not drinking every day

3) Daily drinking: Patient drinks alcohol every day but not during the day time

4) Daytime drinking: Drinking even during the day time.

We also calculated Drinking percentage days as:

Sample size estimation:

32.5% of patients remained abstinent and non-problem drinker at

the end of one year after a routine de-addiction treatment (Abraham J, 1997)

and we hypothesized that Telephone Continuing Care would improve the

abstinent rate to 60%.

The required sample size to detect this difference in the abstinent

rates between the 2 arms (keeping alpha as 0.05 and beta as 0.2), was 34

patients in each arm. Assuming dropout rate as 10%, we needed 38 patients in

ANALYSES:

 Statistical analysis was conducted using SPSS version 19.0 for Windows.

 All variables were checked for normality using the Kolmogorov-Smirnov

test. We did parametric tests for the normally distributed data and did

non-parametric tests for the rest.

 We usedstudent’s t test to compare the following normally distributed

continuous variables: Mean time for the first drink, mean drinking days

percentage, duration of alcohol intake, duration of daily drinking, SADQ

score,

 As the following continuous variables were not normally distributed we

used Mann Whitney U test to compare the mean between the groups:

onset of first drink, number of cigarettes smoked per day, abstinent

episodes, length of abstinence, SCID score, URICA score, duration of

hospital stay, length of follow-up, duration of drug compliance, group

visits and

 Chi-square test and fisher’s exact test were used to compare categorical

variables: marital status, socio-economic status, telephone status,

smoking status, other substance status, co-morbid medical illness, family

components, abstinence medications and primary outcome measures:

number of patients remaining abstinent and relapsed.

 In the whole sample, among patients who had complete data for 6

months, we did bivariate analyses to see whether there is any association

between relapse and the following variables:

o Socio-demographic factors, history of alcoholism in the family

o Features of alcoholism (age of onset of first drink, age of onset of

daily drinking of alcohol, duration of alcohol use, Severity of

Alcohol Dependent Questionnaire score, no. of abstinent episodes,

length of abstinent periods, history of withdrawal seizures, history

of delirium tremens)

o Level of motivation as assessed by URICA scale

o Treatment factors (length of hospital stay for de-addiction,

different components of de-addiction treatment, medications used

to maintain abstinence, drug compliance and length of follow-up in

the clinic).

 We did logistic regression by including all the above variables in the

logistic model to see which variables would predict relapse. We did

Omnibus tests of model coefficients to see the significance of our model

and we did Hosmer and Lemeshow test whether our logistic model is a fit

model.

FIG 1: FLOW CHART DESCRIBING THE METHODOLOGY:

Fulfilling inclusion and

exclusion criteria

Both patient and primary caregiver RECRUITMENT FULFILLING

THE CRITERIA FOR ADS

CRSTUDY SUBJECTS-67

At the time of discharge Randomized into two groups

Telephone Continuing Care (TCC)

Treatment As Usual (TAU)

GROUP THERAPY AND FOLLOW UP IN CLINIC

GROUP THERAPY AND FOLLOW UP IN CLINIC

BRIEF PROACTIVE COUNSELLING AT 1, 2, 4,8,12,16,29,24 WEEKS

NO PROACTIVE COUNSELLING ATTEMPTED

ASSESSMENTS AT 4,8,12,16,20,24 WEEKS

RESULTS

1. Baseline profile of the study sample

2. Comparing primary and secondary outcome measures between Telephone

Continuing Care (TCC) and Treatment As Usual (TAU) groups.

3. The rate of abstinence and relapse among patients for whom we got

complete follow-up data for 6 months (Completers).

4. Among completers, predictors of relapse using bivariate analyses and

logistic regression.

There were 77 patients admitted who fulfilled the criteria for alcohol

dependence during study period. Out of 77 patients, 8 patients were excluded

because of comorbid severe mental disorder and 2 patients were not willing to

consent. Hence, remaining total of 67 patients who fulfilled the inclusion

criteria were randomly assigned to ‘Telephone Continuing Care (TCC)’and

There were 34 patients in the TCC group and 33 patients in the TAU

group. We were able to follow-up and obtain data for 60 patients for the entire 6

months and 7 patients dropped out during the course of the study (TCC=1 and

TAU=6).

1. BASELINE PROFILE OF STUDY SAMPLE:

All patients were males and their mean age was 41.10 years and 91 % of

them were married. Both the groups were comparable in all the

TABLE 1: BASELINE SOCIO DEMOGRAPHIC DETAILS OF THE STUDY SAMPLE VARIABLES TOTAL SAMPLE N=67 Telephone Continuing Care (TCC) N=34(%) Treatment As Usual (TAU) N=33(%) Statistics

Age Mean (S.D)

Marital status n

(%) Married Unmarried Separated Socio economic status Upper (%) Upper middle(%) Lower middle(%) Lower(%)

Telephone status of

TABLE 2: BASELINE CLINICAL CHARACTERISTICS OF THE STUDY SAMPLE VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics Smoking status (%) Present Absent

No of cigarettes Other substance use n (%)

In the total sample, 64.2% of patients were smokers and 20.9% were using

substances like tobacco chewing, cannabis, benzodiazepines and these patients

were equally represented in TCC and TAU groups. A high number of patients

(77.6%) had positive family history of alcoholism.

BASELINE ALCOHOL PROFILE OF STUDY SAMPLE

ONSET OF FIRST DRINK:

Mean onset of first drink of total subjects was 20.82 years. There was no

statistical significance between two groups as shown in Table.3

ONSET OF DAILY DRINKING:

Mean age of onset of daily drinking in our sample was 30.52 years. Telephone

continuing care group was having slightly earlier onset of daily drinking

compared to other group but not statistically significant as shown below in the

Table.3

DURATION OF ALCOHOL INTAKE:

Average duration of alcohol intake of total subjects was 20.25 years. Alcohol

intake duration was not statistically significant between two groups, as it was

TABLE 3: BASELINE ALCOHOL PROFILE OF STUDY SAMPLE VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics

First drink onset

(yrs)

Mean (S.D)

20.82(5.85) 20.41(5.65) 21.24(6.07)

U=486.50, Z= -.941, p=0.72 Daily drinking onset (yrs) Mean (S.D)

30.52(6.55) 29.97(5.64) 31.09(7.42)

U=526.00, Z= -.442, p=0.66 Duration of alcohol intake (yrs) Mean (S.D)

20.25(9.47) 20.29(9.21) 20.21(9.86)

t=0.35,df=65,

ABSTINENT EPISODES PROFILE OF STUDY SAMPLE:

TABLE 4: ABSTINENT EPISODES PROFILE OF STUDY SAMPLE

VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics Abstinent episodes Mean (S.D) 3.69 (4.41) 2.91 (3.62) 4.48(5.03) U=404.50, Z= -2.01, p=0.045* Length of abstinence Mean (S.D) 197.93 (296.63) 189.85 (282.68) 206.24(314.55) U=482.00, z=-.99, p=0.32

Patients in the TCC group had lesser number of abstinent episodes than

TAU group; however there was no statistical difference in the mean length of

HISTORY OF COMPLICATED WITHDRAWAL SYMPTOMS:

TABLE 5:BASELINE HISTORY OF COMPLICATED WITHDRAWAL SYMPTOMS VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics Withdrawal seizures n(%) Absent Present 56(83.6) 11(16.4) 29(85.3) 5(14.7) 27(81.8) 6(18.2) χ2=0.147, df=1, p=0.70 Delirium tremens n (%)

History of delirium tremens was present in 26.1 % of patients and

16.4% had history of withdrawal seizures. There was no statistical significance

between two groups with respect to alcohol withdrawal profile.

BASELINE ALCOHOL SEVERITY PROFILE OF SAMPLE:

SCID SCORE:

Structured Clinical Interview for DSM IV (SCID) dependence module has 7

criteria and our patients fulfilled at least 6 out of the 7 criteria. Average SCID

criteria fulfilled was 6.07 and Mann-Whitney U test didn’t detect anystatistical difference between TCC and TAU groups (Table 6)

SADQ SCORE:

Mean SADQ score of total sample was 29.82, indicating alcohol dependence of

moderate severity. Both TCC and TAU groups had similar mean SADQ profile

(Table.6)

SADQ GRADE:

Patients recruited belong to mostly moderate and severe grade of alcohol

dependence (46.3 % were of moderate dependence and 44% were of severe

Hence the severity of alcohol dependence in the TCC and TAU groups was

similar.

TABLE 6 :BASELINE ALCOHOL SEVERITY PROFILE OF SAMPLE

VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics SCID (No. of criteria fulfilled) Mean(S.D)

6.07(0.96) 6.03(0.93) 6.12(0.93) U=528.50,

Z= -.432,

p=0.66

SADQ Score

Mean(S.D)

29.82(11.03) 30.32(10.27) 29.30(11.90) t=0.376,

BASELINE MOTIVATION PROFILE OF STUDY SAMPLE:

Motivation level at baseline was assessed by URICA-University of Rhode

Island Change Assessment scale.

URICA SCORE and URICA GRADE:

Mean URICA score of total subjects was 11.74 and 58.2 % of total patients

recruited had higher level of motivation i.e. action phase. Both the groups had

almost similar proportion of patients in each level of motivation as shown in

TABLE 7:BASELINE MOTIVATION PROFILE OF STUDY SAMPLE VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics URICA Score Mean(S.D)

11.74(2.58) 11.65(2.81) 11.83(2.36) U=558.00, Z= -.038, p=0.97

DEADDICTION TREATMENT:

Patients admitted in de-addiction ward underwent initial detoxification and

then full de-addiction treatment which comprises of motivational interviews,

cue analysis and cue management, coverts sensitisation, aversion therapy, group

therapy and family therapy.

Although there were differences in the components of de-addiction

treatment received by patients, there were no statistical difference between TCC

DURATION OF HOSPITAL STAY:

TABLE 9: HOSPITAL STAY DURATION

VARIABLES TOTAL SUBJECTS

N=67

TELEPHONE CONTINUING CARE(TCC)

N=34(%)

TREATMENT AS

USUAL(TAU) N=33(%)

Statistics

Hospital stay

duration

Mean (S.D)

14.34(4.65) 13.50(6.53) 15.21(6.76) U=462.00,

Z= -1.245,

p=0.21

Mean length of hospital for total subjects was 14.34 days. Treatment-as-usual

group had slightly longer mean hospital stay of 15.21 days in contrast to 14.34

BENZODIAZEPINE USAGE OF STUDY SAMPLE:

Only 76.1% of patients admitted received benzodiazepine. Others did

not required benzodiazepine for detoxification or prescribed some other drugs

during treatment. Benzodiazepine usage was comparable in both the groups.

TABLE 9:BENZODIAZEPINE USAGE DETAILS OF STUDY SAMPLE

VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics

BZD USAGE

N (%)

ABSTINENCE MAINTAINING MEDICATIONS:

TABLE 11:ABSTINENT MAINTAINING MEDICATIONS

VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics Abstinence maintaining medications n(%) Present Absent 38(56.7) 29(43.3) 18(52.9) 16(47.1) 20(60.6) 13(39.4) χ2=0.40, df=1, p=0.52

At the time of discharge, 56.7% of study subjects were prescribed abstinent

medications. Of these, 37.3 % of them were prescribed disulfiram and the

was no statistical difference between choices of abstinent medications between

two groups.

Thus, there were no significant differences in the intensity and components

of in-patient de-addiction received by patients belonging to TCC group and

TAU group. At the time of discharge also they received similar abstinent

maintaining medications.

2.PRIMARY OUTCOME MEASURES

Primary outcome measures were

1) Abstinence

2) Occasional drinking

3) Daily drinking

4) Daytime drinking

At the end of first month 20.9% of patients had relapsed and

79.1% remained abstinent. On subsequent months, abstinence rate gradually

declined and at the end of 6 months it was 61.7%. At the end of 6 months,

Telephone Continuing Care group having slightly higher abstinent rate of

TABLE 12: ABSTINECE AND RELAPSE OUTCOME IN TCC AND TAU GROUPS: VARIABLES TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics FIRST MONTH Abstinent Occasional drinking Daytime drinking

53(79.1) 3(4.5) 11(16.4) 27(79.4) -7(20.6) 26(78.8) 3(9.1) 4(12.1) χ2=3.82, df=2, p=0.15

SECOND MONTH Abstinent Occasional drinking Daily drinking Daytime drinking 50(74.6) 5(7.5) 2(3) 10(14.9) 26(76.5) 1(2.9) 1(2.9) 6(17.6) 24(72.7) 4(12.1) 1(3) 4(12.1) χ2=2.26, df=3, p=0.52

THIRD MONTH Abstinent

Occasional drinking Daytime drinking

TABLE 13: ABSTINECE AND RELAPSE OUTCOME IN TCC AND TAU GROUPS:

Outcome variables Total Subjects N=67

Telephone continuing Care N =34(%)

Treatment as usual N =33(%)

Statistics

FOURTH MONTH Abstinent Occasional drinking Daily drinking Daytime drinking 41(65.1) 5(7.9) 2(3.2) 11(23.8) 22(66.7) 4(12.1) 1(3) 6(18.2) 19(63.3) 1(3.3) 1(3.3) 9(30) χ2=2.48, df=3, p=0.48

FIFTH MONTH Abstinent Occasional drinking Daily drinking Daytime drinking 37(60.7) 6(9.8) 2(3.3) 16(26.2) 20(60.6) 4(12.1) 1(3) 8(24.2) 17(60.7) 2(7.1) 1(3.6) 8(28.6) χ2=0.50, df=3, p=0.92

ABSTINENCE RATE BETWEEN TWO GROUPS :

FIG 2 :COMPARISON OF ABSTINENCE BETWEEN TWO GROUPS

Fig 2 above shows the comparison of abstinence rate between two groups at the

end of each month but there was no statistical significant difference between

two groups across each month. 79.40%

76.50%

67.60% _66.70%

60.60%

66.40% 78.80% _77.70%

63.60% 63.30%

60.70%

55.60%

1st month 2nd month 3rd month 4th month 5th month 6th month

COMPARISON OF ABSTINENCE BETWEEN TWO

GROUPS

Telephone continuing care Treatment as usual

3.SECONDARY OUTCOME MEASURES

3.1.ONSET OF FIRST DRINK AFTER DISCHARGE:

Mean onset of first drink of patients who underwent de-addiction treatment

was 64.22 days after discharge. There was difference of 7.32 days between two

groups but it was not statistically significant (p=0.11) as shown below in the

table 13.

TABLE 14: COMPARISON OF ONSET OF FIRST DRINK AFTER DISCHARGE BETWEEN TWO GROUPS:

VARIABLES TOTAL SUBJECTS

N=67

TELEPHONE CONTINUING CARE(TCC)

N=34(%)

TREATMENT AS USUAL(TAU)

N=33(%)

Statistics

Onset of first

drink( in days)

Mean(S.D)

64.22(53.9) 60.06(56.82) 67.38(52.76) U=424.00,

z=-1.61,

TABLE 15: DRINKING PERCENTAGE DAYS IN TWO GROUPS:

Months Total

Drinking percentage days

Mean % (S.D)

TCC

Drinking percentage

days

Mean % (S.D)

TAU

Drinking percentage days

Mean % (S.D)

Statistics

FIRST MONTH Total relapsed pts -14

43.08(25.56) 40.45(22.14) 45.70(30.15) U=555.50, z=-0.097, p=0.92

SECOND MONTH Total relapsed pts -19

42.63(30.47) 47.60(28.15) 38.17(33.25) U=545.00, z=-0.252, p=0.80

THIRD MONTH Total relapsed pts -27

36.24(30.88) 36.40(29.04) 36.09(33.59) U=542.00, z=-0.269, p=0.78 FO URTH MONTH

Total relapsed pts -27

37.52(27.43) 44.79(26.07) 31.70(27.96) U=456.00, z=-0.595, p=0.55

FIFTH MONTH Total relapsed pts -30

37.76(27.33) 43.76(26.25) 32.51(28.00) U=431.00, z=-0.481, p=0.63 SIXTH MONTH

Total relapsed pts -32

There was cumulative increase in the relapse rates during successive

months of follow-up and at the end of 6 months there were 32 patients who had

relapsed into drinking. Among these patients, we calculated drinking percentage

days as: Number of drinking days/Total days. As shown above in the Table. No.

15, there was no significant difference between two groups with respect to mean

drinking percentage days at each month.

3.3. DRUG COMPLIANCE:

Telephone continuing care group had higher drug compliance compared

to treatment-as-usual group. Mean drug compliance in telephone group was

91.44 days compared to 63.18 days, which was statistically significant with p

TABLE 16: COMPARISON OF DRUG COMPLIANCE BETWEEN TWO GROUPS OUTCOME VARIABLE TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics Drug compliance(in days) Mean (S.D) 77.52 (65.52) 91.44 (63.76) 63.18 (65.15) U=393.50, z=-2.11, p=0.03*

3.4.LENGTH OF FOLLOW UP:

Mean length of follow up of total subjects was 80.40 days. ‘Telephone

continuing care’had longer follow-up of 99.65 days compared to 60.58 days

TABLE 17: COMPARISON OF LENGTH OF FOLLOW- UP BETWEEN TWO GROUPS OUTCOME VARIABLE TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics

Length of follow up

(days) Mean (S.D) 80.40 (70.53) 99.65 (67.55) 60.58 (68.97) U=347.00, z=-2.73, p=0.06

3.5.GROUP VISITS ATTENDANCE:

In comparing attendance for group visits between two groups, there was

statistical significance with p value of 0.05. Telephone continuing care group

had higher number of mean group visits (1.29) compared to mean of 0.58 visits

TABLE 18: COMPARISON OF GROUP VISITS ATTENDANCE BETWEEN TWO GROUPS:

OUTCOME VARIABLE

TOTAL SUBJECTS

N=67

TELEPHONE CONTINUING CARE(TCC)

N=34(%)

TREATMENT AS USUAL(TAU)

N=33(%)

Statistics

Group

visits

N (%)

0.94

(1.19)

1.29

(1.29)

0.58

(0.96)

U=354.50,

z=-2.78,

3.6. READMISSIONS AFTER DISCHARGE:

19.4 % of total subjects had readmissions after discharge for lapse

of drinking during study period. Of those, there were 6 patients belonging to

telephone continuing care group and 7 patients belonging to treatment-as-usual

group, which was not statistically significant (p=0.58).

TABLE 19: COMPARISON OF RE-ADMISSIONS BETWEEN TWO GROUPS:

OUTCOME VARIABLE TOTAL SUBJECTS N=67 TELEPHONE CONTINUING CARE(TCC) N=34(%) TREATMENT AS USUAL(TAU) N=33(%) Statistics

No of re-admissions

(no of patients )(%)

DROP-OUTS BETWEEN TWO GROUPS:

TABLE 20: COMPARISON OF DROP-OUTS BETWEEN TWO GROUPS

OUTCOME VARIABLE

TOTAL SUBJECTS

N=67

TELEPHONE CONTINUING CARE(TCC)

N=34(%)

TREATMENT AS

USUAL(TAU) N=33(%)

Statistics

Drop–outs Completers

7(10.6)

60 (89.6)

1(2.9)

33(97.1)

6(18.8)

26(81.3)

χ2=4.34,df=1,

p=0.05*

There was higher drop-out rate of 18.8% in treatment-as-usual group compared

to 2.9% in telephone continuing care, which was statistically significant with p

COMPLETERS

Among 67 total subjects, we were able to follow-up and obtain complete

information for 60 patients and we call them as “Completers”.At the end of 6

months, among the completers, 28 patients (46.7%) remained as completely

abstinent and 32 patients (53.3%) relapsed into drinking. We call the former as

‘Abstinence group’and latter as‘Relapse group’.

We assessed the drinking percentage days in the Relapse group and compared

them with their baseline drinking percentage days.

3.2. DRINKING FREQUENCY OF RELAPSED PATIENTS

At the end of each month, there was significant reduction in drinking

percentage percentages of patients who had relapsed after discharge from

hospital, which was also statistically significant with p value of 0.0001 at each

TABLE 21 : COMPARISON OF DRINKING FREQUENCY WITH THEIR BASELINE MONTHS TOTAL RELAPSED PATIENTS DRINKING DAYS MEAN (%) MEAN REDUCTION FROM BASELINE

95 % C.I STATISTICS

FIRST 14 43.08(25.56) -56.92 -71.68 to

-42.16

t=-8.832,df=13, p=0.0001

SECOND 19 42.63(30.47) -57.36 -72.05 to

-42.67

t=-8.204,df=18, p=0.0001

THIRD 27 36.24(30.88) -63.73 -75.97 to

-51.54

t=-10.728,df=26, p=0.0001

FOURTH 27 37.52(27.43) -62.47 -73.33 to

-51.62

t=-11.83,df=26, p=0.0001

FIFTH 30 37.76(27.33) -62.23 -72.44 to

-52.02

t=-12.47,df=29, p=0.0001

SIXTH 32 38.78(27.30) -61.21 -71.05 to

-51.36

At the end of first month after discharge, there was almost 56.92%

reduction in drinking days compared to baseline 100 % drinking days.

Reduction in drinking days percentages gradually climbs as months progress

with statistical significance of p=0.0001 at each month.

At the end of sixth month, there was almost 61.21% reduction in

drinking days compared to baseline 100 % drinking days, which was also

PREDICTORS OF RELAPSE IN COMPLETERS

BIVARIATE ANALYSIS:

Possible factors that would predict risk of relapse were analysed using

bivariate analysis and multiple logistic regression .

Factors such as study arm, caregiver telephone status, basic

socio-demographic details, family history of alcoholism, baseline alcohol profile,

alcohol severity, motivation level, treatment details, abstinent medications,

hospital stay duration, drug compliance, group visit attendance and length of

4.1. STUDY GROUP AND RELAPSE:

There was trend towards significance with p value of 0.06 on analysing

the association of interventional group with relapse for those who completed the

study. Telephone continuing care group had lesser proportion of patients

relapsing into drinking in the 6 months follow-up.

TABLE 22: ASSOCIATION OF STUDY GROUP AND RELAPSE RISK

VARIABLES ABSTINENCE

GROUP

N=28 (%)

RELAPSE

GROUP

N =32 (%)

STATISTICS

GROUP

Telephone continuing care

Treatment as usual

19(67.9)

9(32.1)

14(43.8)

18(56.3)

χ2=3.50, df=1,

4.2. SOCIODEMOGRAPHIC PROFILE AND RELAPSE RISK:

TABLE 23: ASSOCIATION OF SOCIODEMOGRAPHIC FACTORS AND RELAPSE: VARIABLES _ABSTINENCE GROUP N=28 (%) RELAPSE GROUP N=32 (%) STATISTICS AGE Mean(S.D)

40 .00(7.67) 41.28(8.73)

t=-.603, df=58, p=0.54 MARITAL STATUS Married Unmarried Separated 26(92.9) 1(3.6) 1(3.6) 29(90.6) 3(9.4) -χ2=1.92, df=2, p=0.38 EDUCATION Graduate

As shown in the above Table.No.22, there was no statistical significant

association between age, age, marital status, socio-economic status and

Relapse.

4.3. OTHER SUBSTANCE USE AND RELAPSE RISK

On analysing the association of smoking status, number of cigarettes

and other comorbid substance usage with relapse risk in patients who completed

the study, there was no statistical significance of association seen with either of

these factors as shown in the below Table No. Similarly, comorbid physical

illness did not found to have significant association regarding relapse risk.

FAMILY HISTORY AND RELAPSE RISK:

But positive family history of alcoholism had trend towards significant

association with predicting higher chances of relapse. Patients having positive

family history in more than one member had higher chance of relapse (40.6 %)

TABLE 24: ASSOCIATION OF OTHER BASELINE DETAILS AND RELAPSE VARIABLES ABSTINENCE GROUP N=28 (%) RELAPSE GROUP

N =32 (%)

4.5.ASSOCIATION OF CLINICAL FEATURES OF ALCOHOL AND RELAPSE:

TABLE 25: ASSOCIATION OF ALCOHOL PROFILE AND RELAPSE:

VARIABLES ABSTINENCE

GROUP N=28 (%)

RELAPSE GROUP N =32 (%)

STATISTICS

ONSET OF FIRST DRINK 21.21(6.49) 20.50(5.71) U=426.00,z=-.33,p=0.74

DAILY DRINKING ONSET 30.46(5.77) 30.59(7.44) t=-.07,df=58,p=0.94

DURATION OF ALCOHOL

INTAKE 18.79(8.41) 20.81(9.75) t=-.85,df=58,p=0.39

PAST HISTORY OF

LENGTH OF ABSTINENCE 160.75(224.07) 208.19(296.64) U=393.00,z=-.81,p=0.41

WITHDRAWAL SEIZURES Absent Present 23(82.1) 5(17.9) 27(84.4) 5(15.6) χ2=.05, df=1, p=1.00 DELIRIUM TREMENS Absent Present 19(67.9) 9(32.1) 24(75) 8(25) χ2=.37, df=1, p=0.54 WITHDRAWAL PSYCHOTIC DISORDER Absent Present 25(89.3) 3(10.7) 31(96.9) 1(3.1) χ2=1.38, df=1, p=0.24 SADQ SCORE Mean (S.D)

28.50(10.85) 30.31(10.74) t=-.64,

df=58,

Among Completers, none of the alcohol profile factors, such as onset of first

drink, onset of daily drinking , duration of alcohol intake and abstinent episodes

were found to statistically significant in influencing the relapse (shown above in

Table.)

Similarly, history of withdrawal seizures ,delirium tremens and

withdrawal related psychotic disorder were not found to be having any

significant association with abstinence and relapse.

On analysing the association of baseline alcohol severity profile factors

such as SCID score, SADQ score and SADQ grade with abstinence, there was

no statistical significant association with baseline alcohol profile and abstinence

4.9. ASSOCIATION OF TREATMENT VARIABLES AND RELAPSE:

TABLE 26: ASSOCIATION OF TREATMENT VARIABLES AND RELAPSE

VARIABLES ABSTINENCE

GROUP

N=28 (%)

RELAPSE

GROUP

N =32 (%)

STATISTICS URICA GRADE Precontemplation Contemplation Action 4(14.3) 10(35.7) 14(50) 3(9.4) 8(25) 21(65.6) χ2=1.50, df=2, p=.45 HOSPITAL STAY DURATION Mean (S.D)

15.68(6.95) 13.25(6.25) U=353.00,

z=-1.41, p=.15 ABSTINENCE MAINTAINING MEDICATIONS N(%) Absent Present 10(35.7) 18(64.3) 16(51.6) 16(50) χ2=1.24, df=1, p=0.26

Length of hospital admission

>3 weeks < 3 weeks

Motivational level assessed by URICA was also analysed for possible

association with abstinence model, but neither URICA score nor URICA grade

was found to be statistically significant in predicting abstinence.

Treatment profile factors such as benzodiazepine use, mean duration

of hospital stay and abstinent medications were analysed for possible influence

on outcome. But neither of the factors was found to be having any predicting

influence on abstinence.

81.3 % of patients who had relapsed had hospital admission less

than 3 weeks whereas 66.67 % of patients admitted atleast three weeks

were found to be remaining abstinent. Length of hospital admission more

than or equal to three weeks was found to be having positive predicting

influence on outcome.

While hospital admission less than 3 weeks was found to be having three

times higher chance of relapse (Odds Ratio of 3.25 and 95% C.I of 1.018

4.12. ASSOCIATION OF FOLLOW UP TREATMENTS AND RELAPSE:

TABLE 27: ASSOCIATION OF FOLLOW UP TREATMENTS AND RELAPSE:

VARIABLES ABSTINENCE

GROUP

N=28 (%)

RELAPSE

GROUP

N =32 (%)

STATISTICS

DRUG

COMPLIANCE

123.21(59.07) 42.09(45.46) U=129.50, z=-4.76, p=0.0001*

GROUP VISITS 1.39(1.44) 0.59(0.79) U=306.50,

z=-2.25, p=0.024*

LENGTH OF FOLLOW UP

107.14(68.5) 62.19(69.33) U=271.50,

z=-2.68, p=0.008*

Patients having higher drug compliance, higher attendance for group

visits and longer follow-up were found to be statistically significant in

MULTIPLE LOGISTIC REGRESSION:

4.13.RESULTS OF MULTIPLE LOGISTIC REGRESSION:

TABLE 28: MULTIPLE LOGISTIC MODEL OF RELAPSE RISK

VARIABLES B S.E SIGNIFICANCE EXP(B)

Demographic details Age Marital status (single/separated) Socioeconomic status Smoking status Family history of alcoholism >1 member =1 member Alcohol profile SADQ score Duration of alcohol intake

Motivation profile URICA score Treatment profile Study group

Duration of hospital stay

Poor drug compliance

For our logistic model, on applying Hosmer and Lemeshow test, p value

came as 0.263 and hence logistic regression analysis is possible. Omnibus tests

of model coefficients, p value is <0.0001; hence our logistic model is a

significant model to predict relapse.

Possible confounding variables such as age, marital status,

socio-economic status, smoking status, family history of alcoholism, baseline alcohol

profile, baseline motivational level, study group, duration of hospital stay and

drug compliance were entered as co-variates keeping Relapse as dependent

variable in the multiple logistic regression analysis.

Family history of alcoholism and drug compliance was found to be

statistically significant in predicting the relapse risk. Positive family history of

alcoholism in one member was found to be having trend towards significance in

predicting relapse whereas positive family history in more than one family

members was found to be having higher risk of relapse with statistical

significance of p value =0.013 and odds ratio of 23.813.

Poor drug compliance was another factor significantly predicting relapse

DISCUSSION

Our randomized controlled study was designed to evaluate the effectiveness of

telephone continuing care in managing alcohol dependence syndrome. Also, the

6 month data obtained for the whole group was used to build a model that

would predict relapse.

To start with, we had recruited a homogenous patient population who fulfilled

the DSM IV TR criteria for alcohol dependence and admitted for de-addiction

treatment. Their baseline socio-demographic details, clinical profile and

baseline features of alcohol appear to be generalizable as they were similar to

other published Indian studies [17, 37, 38].

The mean age of our patient group was 41.10 years and they had been drinking

alcohol since the age of 20 and for at least for the last 10 years they had been

drinking daily. As rated by SADQ, most of them (91%) had moderate to severe

dependence. Most of them (58.2 %) had action level of motivation, as assessed

Table 29: Comparison of demographic and baseline alcohol profile of our

study sample with other Indian outcome studies

Variable Our Study

Results Kar et al,2003 Chandrasekaran et al,2001 Abraham et al,1997 Mean age (S.D) 41.09 yrs(8.63)

30.8 yrs(8.5) 39.7 yrs(8.66) 39.6 yrs(8.5)

Age of onset

of first drink

(S.D)

20.82 yrs

(5.85)

NA 23.18 yrs

(6.92)

23.15(7.2)

Age of onset

Table 30 : Comparison of Positive family history of alcoholism with

outcome studies

Variable Our Study

Results

Kar et

al,2003

Chandrasekara

n et al,2001

Abraham et

al,1997

Positive

family history

of alcoholism

77.6% 66.2 % 67.1% 54.25%

Another interesting finding was 77.6% of recruited patients had positive

family history of alcoholism, which was similar to previous Indian outcome

studies. [17, 37, 38]

Primary outcome measures:

On analysing the primary outcome measures between the two groups, at the

end of 6 months, complete abstinence rate was 66.4% in Telephone

continuing care (TCC) group and 55.6% in Treatment-as-usual group

(TAU). Though numerically TCC group appears better than TAU group, this

Table 31 : Comparison of abstinence rate between two groups at each

month

Telephone

continuing care

Treatment as

usual

P value

1st month 79.4% 78.8% 0.15

2ndmonth 76.5% 77.7% 0.52

3rdmonth 67.6% 63.6% 0.52

4thmonth 66.7% 63.6% 0.48

5thmonth 60.6% 60.7% 0.92

6thmonth 66.4% 55.6% 0.35

However, in the Completers group (6 month complete date obtained)

the difference in the abstinence rate is even larger. In completers, the abstinence

rate in TCC group was 67.9%, whereas in TAU group it was 32.1% and this

difference showed trend towards significance (p=0.06)

This is in contrast to earlier studies done in the west, which showed a better

significant reduction in drinking percentage days. Our study couldn’t replicate such significance because of small sample size. Another reason could be that

our study duration was short. Mckay et al showed significant better results only

in 24 months longer outcome studies [3]. Hence we speculate that a large

sample size with longer duration of study the advantage of Telephone

continuing care could become significant.

Also in addition, still adequate face to face interviews might be needed to hold

on the benefits of telephone continuing care.

Secondary outcome measure:

Telephone continuing care group performed better than

treatment as usual group in terms of good drug compliance, longer length of

follow-ups in clinic and better attendance for group therapy. There was

significant statistical difference between two groups in the above parameters.

Many studies also demonstrated similar results [3, 6].Godley et al [6]

demonstrated better attendance for group visits and follow-up in clinic.

of treatment adherence and follow-up at the end of 3 months. But these results

were not replicated at the end of 12 months.

Figure 3: Comparison of drug compliance between two groups

50 70 90

Telephone continuing care Treatment-as-usual

Dr

ug

co

m

pl

ia

nc

e(

in

d

ay

s)

With respect to compliance to drug regimen, telephone continuing care

had mean drug compliance of 91.44 days compared to 63.18 days of treatment

as-usual group.(p=0.03).

Figure 4: Comparison of length of follow up between two groups

50 70 90

Telephone continuing care Treatment-as-usual

Le

ng

th

o

f f

ol

lo

w

up

( i

n

da

ys

)

Similarly, there was trend towards significance in terms of length of

follow up between two groups (99.65 days in telephone continuing care group

vs 60.58 in treatment-as-usual, p=0.06).

Also, attendance of group visits was higher in telephone continuing

care group and there was statistical significance when compared to

treatment-as-usual group. (1.29 visits versus 0.58 visits, p=0.05)

Regarding other secondary outcome measures such as onset of first drink,

drinking days percentages and number of re-admissions, there was no statistical

difference between two groups.

EFFECTIVENESS OF DE-ADDICTION TREATMENT:

Our de-addiction treatment regimen includes detoxification,

motivational interviews, cue analysis, aversion therapy, covert sensitization,

family and group therapy. Finally at the time of discharge, we used to prescribe

abstinent medications and advised to come for regular follow-up. Many tertiary

centres have de-addiction treatment with the above components [17, 38]

Even though abstinent rate and drinking percentage days among patients

who had did not differ statistically between the two groups, the effectiveness of

the de-addiction programme for the whole sample was very encouraging. For

the whole sample, the complete abstinence rate and drinking percentage days